消癖口服液1号质量标准提升研究  

Improvement the quality standards for Xiaopi Oral Liquid No.1

作　　者：汤婷婷 胡耶芳[1] 颜剑 胡娜拉 郭远明 林玲[1] 谢钰珩 TANG Tingting;HU Yefang;YAN Jian;HU Nala;GUO Yuanming;LIN Ling;XIE Yuheng(Guilin Municipal Hospital of Traditional Chinese Medicine,Guilin 541002,China)

机构地区：[1]桂林市中医医院,桂林541002

出　　处：《华夏医学》2025年第1期37-43,共7页Acta Medicinae Sinica

基　　金：广西壮族自治区中医药管理局自筹经费科研课题(GXZYC20220491)。

摘　　要：目的为进一步提升自制中药消癖口服液1号的质量标准,确保临床用药的安全性和有效性,在其原检验方法的基础上,新增薄层色谱法(TLC)对制剂进行检测。方法运用薄层色谱法,针对该制剂中的两个主要药材成分丹参和当归,设计特定薄层条件开展定性鉴别。结果在定性鉴别实验中,丹参和当归的薄层斑点均呈现出圆整、清晰的特征,Rf值0.2~0.8较为理想,分离度良好。日光灯下检视,丹参鉴别项供试品色谱中,与丹参对照药材色谱和丹酚酸B对照品色谱对应斑点的Rf值为0.5,显粉红色。紫外光灯(波长为365 nm)下检视,当归鉴别项供试品色谱中,与当归对照药材色谱和阿魏酸对照品色谱对应斑点的Rf值为0.5,显蓝色荧光。同时,阴性对照色谱图中相应位置未出现相同颜色的斑点。结论本研究建立的薄层鉴别法具有操作简便、重现性好、阴性对照无干扰等优点,确定该方法可用于消癖口服液1号中丹参和当归的定性鉴别分析。Objective To further enhance the quality standard of Xiaopi Oral Liquid No.1,a traditional Chinese medicine preparation in hospitals,and to ensure the safety and efficacy of clinical medication,a new thin-layer chromatography(TLC)method was added on the basis of the original inspection approach for the detection of the preparation.Methods By applying the thin-layer chromatography,specific thin-layer conditions were designed for the two main medicinal ingredients in the preparation,namely Salvia miltiorrhiza and Angelica sinensis,to conduct qualitative identification.Results In the qualitative identification experiment,the thin-layer spots of Salvia miltiorrhiza and Angelica sinensis both presented round and clear characteristics,with ideal Rf values(0.2 to 0.8)and good separation.Under daylight lamp examination,in the chromatogram of the test sample for the identification of Salvia miltiorrhiza,the Rf value of the corresponding spots in the chromatogram of the reference medicinal material of Salvia miltiorrhiza and the reference substance of salvianolic acid B was 0.5,showing pink.Under ultraviolet lamp(365 nm)examination,in the chromatogram of the test sample for the identification of Angelica sinensis,the Rf value of the corresponding spots in the chromatogram of the reference medicinal material of Angelica sinensis and the reference substance of ferulic acid was 0.5,showing blue fluorescence.Meanwhile,no spots of the same color appeared at the corresponding positions in the negative control chromatogram.Conclusion The thin-layer identification method established in this study has the advantages of simple operation,good reproducibility,and no interference from the negative control.It is determined that this method can be used as the qualitative identification and analysis method for Salvia miltiorrhiza and Angelica sinensis in Xiaopi Oral Liquid No.1.

关 键 词：消癖口服液1号 质量标准 薄层色谱 丹参 丹酚酸B 当归 阿魏酸 

分 类 号：R593.22[医药卫生—内科学]